The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of ISIS 353512, to evaluate the blood concentration and rate elimination of ISIS 353512 from the blood, and to evaluate the effectiveness of ISIS 353512 in lowering a protein in the blood associated with inflammation.

Double Blind, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 353512 Administered Intravenously and Subcutaneously to Healthy Volunteers

Further study details as provided by Isis Pharmaceuticals:

Primary Outcome Measures:

To evaluate the safety and tolerability of single and multiple doses of ISIS 353512 administered intravenously and subcutaneously. [ Time Frame: 14 Days post treatment of each cohort ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the pharmacokinetic profile of single and multiple doses of ISIS 353512 administered intravenously and subcutaneously. [ Time Frame: 14 Days post treatment of each cohort ] [ Designated as safety issue: No ]

To evaluate the pharmacodynamics of ISIS 353512 administered intravenously and subcutaneously. [ Time Frame: 14 Days post treatment of each cohort ] [ Designated as safety issue: No ]

2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8

Detailed Description:

This will be a Phase 1, double blind, placebo-controlled, dose-escalation study conducted at a single center to 1)evaluate the safety and tolerability of single and multiple doses of ISIS 353512 administered intravenously and subcutaneously, 2)evaluate the pharmacokinetic profile of single and multiple doses of ISIS 353512 administered intravenously and subcutaneously, and 3)evaluate the pharmacodynamics of ISIS 353512 in lowering constitutive levels of c-reactive proteins in healthy volunteers.

Eligibility

Ages Eligible for Study:

18 Years to 55 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Age 18 to 55 years

Male or female although females must be post-menopausal or surgically sterile

Use of soft drugs (such as marijuana) within 3 months prior to Screening or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to Screening, or positive urine drug screen at Screening

Smoking > 10 cigarettes per day

Use of an investigational drug or participation in an investigational study involving a small molecule with 30 days prior to dosing or participation in an investigational study involving biologic compounds within 90 days prior to dosing

Receiving prescription medications, including hormone replacement therapy, statins, TNF-α inhibitors, or other anti-inflammatory or immunosuppressive drugs within 30 days prior to Screening

Immunization with a live attenuated vaccine one month prior to dosing or planned vaccination during the course of the study

Blood donation of 50 to 499 mL within 30 days of Screening or of > 499 mL within 60 days of Screening

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734240